A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder



Status:Recruiting
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:2/28/2019
Start Date:February 14, 2019
End Date:June 2021

Use our guide to learn which trials are right for you!

An Open-label, 52-Week, Multicenter Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder

This study will evaluate the long-term safety and tolerability of centanafadine
sustained-release tablets, administered twice daily in the treatment of adults with ADHD.

This open-label study will assess the overall safety and tolerability of 400 mg total daily
dose centanafadine sustained-release tablets in subjects, over the course of approximately 52
weeks. This study will accept rollover subjects from both the 405-201-00013 and 405-201-00014
trials. For individuals that did not participate in one of the studies mentioned above, they
will be able to enroll if they meet the inclusion criteria as outlined below.

De Novo Subjects

Inclusion Criteria:

- De novo subjects must meet the Diagnostic and Statistical Manual of Mental Disorders,
Fifth Edition (DSM-5) criteria for ADHD (including predominantly inattentive
presentation, hyperactive presentation, or combined presentation) as confirmed by the
Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2. To confirm that ADHD is the
primary diagnosis, the Mini International Neuropsychiatric Interview (MINI) will be
used to identify and exclude other psychiatric conditions which would preclude
enrollment.

- Subjects are 18 to 55 years of age, inclusive, at the time of consent.

- Subjects have BMI of 18 to 40, inclusive

- Subjects are willing to discontinue all prohibited psychotropic medications starting
from the time of signing the informed consent and up to the 10-day safety follow-up
period.

Exclusion Criteria:

- Subject has a DSM-5 diagnosis of Other Specified or Unspecified
Attention-Deficit/Hyperactivity Disorder as confirmed by ACDS Version 1.2.

- Subject has a current comorbid psychiatric disorder that is either controlled with
medications prohibited in this trial or is uncontrolled and associated with
significant symptoms, including but not limited to: a current major depressive episode
(per DSM-5 criteria), current symptoms (past 90 days) meeting the DSM-5 criteria for a
diagnosis of generalized anxiety disorder, obsessive compulsive disorder, panic
disorder, or posttraumatic stress disorder, as established by the MINI. NOTE: Subjects
with mild mood or anxiety symptoms that do not meet criteria for diagnosis, who do not
require treatment based on the Investigator's assessment, and do not confound efficacy
or safety assessments in the opinion of the examining Investigator, may be included.

- Subjects that have a positive alcohol test (via breathalyzer or blood), a positive
drug screen for cocaine, or other illicit drugs (excluding marijuana). Subjects with a
positive drug screen for confirmed prescription medications at baseline will not be
permitted to continue participation in Trial 405-201-00015. NOTE: Subjects that tested
positive for marijuana may be permitted to be enrolled if they have no evidence of a
substance use disorder, and if they agree to refrain from use for the duration of the
trial. Allowance for subjects testing positive for marijuana at screening require
explicit approval from the medical monitor.

Rollover Subjects

Inclusion Criteria:

- Subjects who completed the double-blind treatment period and 7-day follow-up after
last dose of investigational medicinal product (IMP) in double-blind trials and who,
in the opinion of the investigator, could potentially benefit from centanafadine for
ADHD.

Exclusion Criteria:

- Subjects who, during the double-blind phase 3 trial experienced, in the opinion of the
investigator, poor tolerability to trial medication or whose safety assessments
resulted in new concerns that would suggest the subject may not be appropriate for a
52-week treatment with trial medication.

- Subjects who have re-initiated any therapy for adult ADHD during the 7-day follow-up
period after the final treatment visit of the double-blind phase 3 trial.

- Subjects that have a positive alcohol test (via breathalyzer or blood), a positive
drug screen for cocaine, or other illicit drugs (excluding marijuana). Subjects with a
positive drug screen for confirmed prescription medications at baseline will not be
permitted to continue participation in Trial 405-201-00015. NOTE: Subjects that test
positive for marijuana may not be permitted to rollover into the open label study, and
must agree to refrain from use for the duration of the open label trial. Allowance for
subjects testing positive for marijuana at time of rollover requires explicit approval
from the medical monitor.
We found this trial at
78
sites
3212 Cove Bend Drive
Tampa, Florida 33613
Phone: 813-971-8311
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Allentown, Pennsylvania 18104
Phone: 610-820-0342
?
mi
from
Allentown, PA
Click here to add this to my saved trials
2150 Peachford Road
Atlanta, Georgia 30338
Phone: 770-458-0447
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
3015 Flowers Road South
Atlanta, Georgia 30341
Phone: 770-817-9200
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78737
Phone: 512-898-9362
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21208
Phone: 410-602-1440
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
3570 Warrensville Center Road
Beachwood, Ohio 44122
Phone: 216-526-1843
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Beavercreek, Ohio 45432
Phone: 937-429-2422
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
2026 Wirt Road
Bellaire, Texas 77401
Phone: 713-527-8839
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
Berlin, New Jersey
Phone: 856-753-7335
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
436 North Roxbury Drive
Beverly Hills, California 90210
Phone: 424-284-3171
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Biloxi, Mississippi 39531
Phone: 251-455-4192
?
mi
from
Biloxi, MS
Click here to add this to my saved trials
Bradenton, Florida
Phone: 941-756-8680
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Cedarhurst, New York 11516
Phone: 516-295-7230
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Charleston, South Carolina 29405
Phone: 843-576-6750
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Phone: 800-785-3150
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28226
Phone: 800-785-3150
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
Phone: 719-634-6576
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Coral Springs, Florida 33067
Phone: 954-796-8222
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
Culver City, California 90230
Phone: 424-227-8127
?
mi
from
Culver City, CA
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-369-2600
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30030
Phone: 404-537-1281
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Encino, California 91316
Phone: 818-705-7451
?
mi
from
Encino, CA
Click here to add this to my saved trials
Gainesville, Florida 32607
Phone: 352-333-0094
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Garden Grove, California 92845
Phone: 714-799-7799
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Glendale, California 91204
Phone: 888-255-5798
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hialeah, Florida 33012
Phone: 786-536-4177
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-281-5757
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Katy, Texas 77450
Phone: 919-931-8941
?
mi
from
Katy, TX
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
Phone: 337-564-6405
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lakeland, Florida 33805
Phone: 863-940-2087
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89128
Phone: 702-838-0742
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderhill, Florida 33319
Phone: 954-990-6326
?
mi
from
Lauderhill, FL
Click here to add this to my saved trials
Lemon Grove, California 91945
Phone: 619-303-6130
?
mi
from
Lemon Grove, CA
Click here to add this to my saved trials
Libertyville, Illinois 60048
Phone: 847-549-7214
?
mi
from
Libertyville, IL
Click here to add this to my saved trials
8550 Cuthills Circle
Lincoln, Nebraska 68526
Phone: 402-817-2235
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Alamitos, California 90720
Phone: 714-827-3668
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
Maitland, Florida 32751
Phone: 407-644-1165
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Marietta, Georgia 30060
Phone: 770-422-2846
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Memphis, Tennessee 38119
Phone: 901-843-1045
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33166
Phone: 305-909-2505
?
mi
from
Miami, FL
Click here to add this to my saved trials
11750 Southwest 40th Street
Miami, Florida 33175
Phone: 786-600-0012
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33155
Phone: 305-433-6496
?
mi
from
Miami, FL
Click here to add this to my saved trials
Midlothian, Virginia 23114
Phone: 804-893-2273
?
mi
from
Midlothian, VA
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
Phone: 843-856-3784
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
New York, New York 10021
Phone: 212-288-0138
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10128
Phone: 212-595-5012
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10168
Phone: 212-772-3570
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
Phone: 949-752-7910
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
1010 24th Avenue Northwest
Norman, Oklahoma 73069
Phone: 405-701-8999
?
mi
from
Norman, OK
Click here to add this to my saved trials
North Richland Hills, Texas 76180
Phone: 817-595-3399
?
mi
from
North Richland Hills, TX
Click here to add this to my saved trials
Norwalk, Connecticut 06851
Phone: 203-838-0070
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
O'Fallon, Missouri 63368
Phone: 636-244-3593
?
mi
from
O'Fallon, MO
Click here to add this to my saved trials
Oceanside, California 92056
Phone: 760-639-4378
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
Phone: 405-286-2104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orem, Utah 84058
Phone: 801-356-5555
?
mi
from
Orem, UT
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 407-425-5100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32807
Phone: 407-440-4493
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 407-425-5100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pembroke Pines, Florida 33024
Phone: 954-342-9557
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-276-6224
?
mi
from
Portland, OR
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-972-9837
?
mi
from
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina 27609
Phone: 919-872-5900
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Redlands, California 92374
Phone: 909-792-9007
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Richardson, Texas 75080
Phone: 214-396-4844
?
mi
from
Richardson, TX
Click here to add this to my saved trials
Rochester, New York 14618
Phone: 585-241-9670
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rochester Hills, Michigan 48307
Phone: 248-608-8800
?
mi
from
Rochester Hills, MI
Click here to add this to my saved trials
Salem, Oregon 97301
Phone: 503-540-0100
?
mi
from
Salem, OR
Click here to add this to my saved trials
San Diego, California 92123
Phone: 858-278-3647
?
mi
from
San Diego, CA
Click here to add this to my saved trials
851 Main Street
South Weymouth, Massachusetts 02190
Phone: 781-849-7766
?
mi
from
South Weymouth, MA
Click here to add this to my saved trials
Tampa, Florida 33609
Phone: 813-849-5566
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida 33634
Phone: 813-877-8839
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Upland, California 91786
Phone: 909-920-3000
?
mi
from
Upland, CA
Click here to add this to my saved trials
3300 Seymour Highway
Wichita Falls, Texas 76309
Phone: 940-322-1131
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials